United Science: product manufacturing, cannabis and hemp processing – Health Europa

United Science: product manufacturing, cannabis and hemp processing - Health Europa

After years of hard work, United Science has transformed its science and engineering expertise and real-world experience, but as said by CEO, Dr Jon Thompson: “Our experience goes deeper than just consulting”.

The medical cannabis and hemp markets are showing explosive growth worldwide. The up and coming European hemp and medical cannabis industry is offering exciting opportunities for entrepreneurs to start and grow a science-based extraction business. Market reports show that now is a great time to start an extraction business as the market is far from mature.

United Science puts people in the extraction business by leveraging its scientific and engineering expertise in extraction, filtration, distillation, commutation, formulations, and facility design with our judicious expertise.

United Science’s selection of equipment, combined with proprietary training and standard manufacturing documentation, by our expert scientists and engineers have a proven track record of shortening our client’s time-to-market.

While traditional medical marijuana addresses high tetrahydrocannabinol (THC) formulations, European courts have defined hemp as a strain of Cannabis Sativa with a THC content less than 0.2% wet weight (w/w). THC is the active ingredient in cannabis responsible for its psychoactive and euphoric effects.

Cannabidiol (CBD) is another type of cannabinoid that is produced in significant quantities in hemp plants, however it does not carry the same intoxicating effects as THC.

Although cannabis and hemp businesses are completely distinct, they are very similar from a manufacturing and processing workflow standpoint. Key differences have to do with scale; equipment and associated facilities for hemp are typically bigger due to the large amounts of biomass processed in a hemp business.

United Science’s team of PhD and MSc scientists, engineers and process chemists have many decades of chemical separation science experience with specific experience in regulated cannabis and hemp extraction and manufacturing. Regulatory and compliance experience within our team includes installations that are Canadian GPP, US cGMP (hemp processing), and European GMP.

Over the past several years, we have collaborated with a wide variety of customers to meet their production needs. Our product offering recognises the importance of selecting pieces of equipment that work together as one comprehensive extraction system with an emphasis on user requirements, methods validation, data integrity, analytical testing, calibration, equipment training and facility commissioning. As each situation is slightly different, we tailor our offering to meet both your business and scientific goals.

United Science CEO, Dr Jon Thompson, spent many years collaborating with European engineers and scientists creating new and innovative fluidic and separations components prior to entering the hemp and cannabis processing market in 2014. “We have pushed the boundaries of science and engineering while maintaining European industrial design principles and compliance” says Thompson.

After years of hard work, United Science has transformed its science and engineering expertise and real-world experience within the fluidics and detection technology into the leading cannabis/hemp CO2 extraction equipment manufacturer and GMP consulting and service provider.

The European hemp and cannabis industries are moving quickly toward safety with quality regulations that are modus operandi in Europe already. In the end, the most energy efficient, green and highly engineered means of production will see the most revenue, while offering patients the lowest priced products and medicine.

Enter the full solution: turnkey extraction facility

If you’re a new investor or entrepreneur, it is likely you have spent countless hours investigating options that often result in confusing and or conflicting claims and mismatched comparisons. There’s a plethora of information out there, some good and some bad. Our approach is to address the manufacturing system as a whole by eliminating the problems that occur upon integrating technology that is not designed to scale or operate together.

Process diagram layer 1: equipment, training, and commissioning

Fig. 1 illustrates a general manufacturing and extraction process that is followed by almost all medical and hemp manufacturers involved in oil production. Although the figure looks simple, there are multiple layers of complexity which any operation will need to address. In the following paragraphs, we examine some of the key factors for start-up processing success.

Each process shown in Fig. 1 requires equipment that is designed and commissioned with methods that are validated and operated by trained personnel. Full solution turnkey processing offerings from United Science includes the following equipment and services:

extraktLAB® Extractors: we manufacture best in class supercritical CO2 extractors that offer low power, small footprint, zero carbon footprint and high throughput;
CO2 Cage® and Pump Cart®: microbulk gas solution for conditioned CO2 delivery to the extractor. The integrate smart system monitors pressure, temperature and weight and provides an automated refill via the pump cart or alternatively by the automated refill email to the CO2 supplier;
igwLAB®: manufacturing execution software that puts all the pieces together including calibration, training, weights, lot tracking, expiration dates, equipment tracking, SOPs, document control, and master batch analytical testing;
CarbonXTM: the nanostructured ‘non-carbon’ carbon that is non-friable and brightens up extract colouring by removing impurities;
DrainDroyd®: legendary filtration unit named as one of the top ‘10 Killer Technologies’ for the cannabis industry by Marijuana Business Magazine along with variations including the condenser droyd. This unit has many attachments to accomplish filtration, and fluid transfers;
facility design: our experts will help you optimally layout your extraction facility including hazardous waste, flammable storage, HVAC calculations, heat load, and P&IDs for services;
distillation equipment: distillation equipment for production of high potency distillate, rapid evaporation of volatile solvents, vacuum distillation and recovery condensers;
isolate production equipment: we manufacture large HPLC equipment (column diameter) and other isolate production equipment for your isolate or full spectrum product;
commissioning packages: convenient equipment installation, method training, and full commissioning; and
SOPs and Formulations: our PhD scientists will get your facility up and running with end product formulation and GMP standard operating procedures to ensure quality production.

Processes shown in Fig. 1 require equipment that has been sized properly to prevent costly build-ups of inventory in between each of the processes. It should be emphasised that often two or more of these processes shown can be combined in a single piece of equipment or eliminated altogether from the workflow based on the desired products that will be produced. The order of the steps may also change in order based on your workflow goals. Fundamental to success in your operations will be to have a working framework of material and information flow.

From a quality perspective, user requirements specification (URS) documents are used to help the customer define acceptable criteria. As a manufacturer, we offer complimentary factory acceptance testing (FAT) and site acceptance testing (SAT) services to our customers to help with documentation. GMP compliance is of paramount importance to your business plan, as well as a science-based approach.

Process diagram layer 2: quality control and yields

Yet another level of complexity involves how the process is measured throughout the entire operation. One key component of our offering is on-site training and training certification for your staff. We provide training on equipment, documented processes, testing protocols and sampling protocols for any aspiring GMP or ISO accredited extraction facility. We record training events inside of the igwLAB’s software so that training records for each operator can be managed. We have found training is key to early success in any type of extraction business, whether it is butane, CO2 or ethanol.

Process diagram layer 3: standard systems for measuring the process

In Fig. 1 our experts ‘measure the system to manage the system.’ The simplified process starts with receiving materials, visual inspection, quality control (analytical), quality assurance disposition, lot number assignment, weigh in and other key activities. Materials can include biomass materials, excipients used in formulations, solvents, calibration standards or any other raw material that may be used in manufacturing and needs to be tracked from a quality standpoint.

Our igwLAB offering is a cloud-based manufacturing execution system that has been made specifically for hemp and cannabis workflows. The process tracks quality disposition, lot characteristics, calibration records, expiration dates, analytical results, training records, lots, waste, yields, SOPs, documentation control, labour content, data integrity and standard reporting including batch records featuring in-category tracking. Software paired with and matched with the appropriate hardware for each step of the process is key to managing quality reporting.

One key aspect to any operation is incoming quality control; in-process quality control, and finished goods quality control. We work with you to create a robust quality control plan to ensure that sampling, analytical results, controlled documents, training, and quality disposition are all built into the workflow.

We have the analytical capability to help your company identify the measurements, equipment, and methods that you need to accomplish in processing quality control. This includes in-process cannabinoid potency, purity, and identity in a wide variety of matrices thus enabling the tracking of yield processes. Those new to the business will likely be trying to obtain a yield model to build pro forma financial projections. We can help you build a realistic pro forma for your investors.

It is important to note that consistency of yield for each of these processes will depend on the consistency of the input to the process. For example, biomass is notoriously inconsistent in potency even within a lot because it has not been homogenised. This is shown in the potency histogram chart below. This means that the overall yield can vary radically just by processing a lot with a significant variable in potency. We are here to help you build a rational yield model that will account for variations and give you a range of outputs so you can model your revenue.

Thompson emphasises that “There is no single answer on yield; only a distribution of answers. Single yield models are always wrong and create expectations that often can’t be delivered upon. It is better to understand variation first as a function of each process and then move on to the averages.”

Process diagram layer 4: anticipating your scale-up

We tailor your turnkey facility to get you where you’d like to be in terms of input and production output, which makes scaling up to meet increased market demand a breeze. Our smallest extractors are appropriate for 5-10,000 ft2 grows and our large 10-tonne per day solutions address the larger scale outdoor hemp operations.

In terms of equipment sizing and selection, we have always recommended a crawl, walk, and then run strategy. Many of our largest customers started out very small with only a single extractor and are now servicing multiple million square metres of indoor grow and multiple thousands of hectares of hemp. The bottom line is that equipment must work together, and it must be used with methods that record data at each process that will allow the entire process to be managed to accomplish the business’ goals.

There are some key advantages to scaling up with extraktLAB. First, our proprietary supercritical CO2 extraction technology gives businesses a small physical footprint thus enabling high throughput in a small space. For example, our mid throughput 1 tonne extraction solution is 800 ft2, runs on 450 amps at 208 V, 3 phase, 50 hertz, and can process 900-1,000 kg a day depending on the potency of the input material. Clean and green CO2 processes also offer key advantages over ‘solvent’ or ethanol based extraction solutions.

These key advantages include:
Avoiding ‘special hazardous classifications’ and limitations on facilities imposed by storage of large amounts of volatile solvents;
significantly lower cost of ownership and lower extraction costs compared to other solvent-based extraction methods;
ability to maintain ‘organic’ certified extracts with ‘organic’ certified biomass;
avoiding special ethanol tax situations and reimbursements of excise taxes; and
no need to revalidate solvents upon re-use, thus greatly lowering variable testing costs.Supercritical CO2 extraction is unique in that operating and solvent costs will stay low, while product consistency between batches remains the same as you scale the operation. Again: the most efficient means of production that offers consumers affordable medicine will win out in the end. The ability to scale to increasing demand is an essential part of any growing industry.
Process diagram layer 5: time to market

There is no doubt that any startup can hire an expert, and then have that expert try to extract all this information from various vendors in hopes of them putting together the right workflow, equipment and processes to match. The concept of, ‘let me borrow your watch to tell you what time it is,’ does not work in a startup environment.

Thompson’s observation is that, “our most successful customers utilise our company as an extension of their team to deliver GMP facilities, equipment, process, method, and validation information that we have accumulated, thereby traversing the usual lengthy time to market.”

No startup is a perfectly executed endeavour; however, there is no doubt that the team at United Science provides an invaluable service that helps you and your colleagues navigate through this ever-changing industry.

What’s the secret to early success in the young hemp and cannabis industry?

Turning relatively inexpensive raw cannabis and hemp biomass into extracts can turn a decent profit margin if the business is managed properly. Customers are consuming more oils, tinctures, edibles and vape cartridges than ever before, while showing no signs of slowing down; there’s no doubt that CBD is becoming a widely discussed world phenomena. The demand is there, but the supply of quality product has been lagging due to the growing pains of an industry in its infancy across the board.

Here’s the cannabis extract market size from 2018, according to Grand View Research: “The global cannabis extract market size was estimated at USD 5.3bn (~€4.7bn) in 2018, with the oil segment accounted for the largest revenue share and was valued at USD 3.5bn. This segment is also expected to witness the fastest growth rate over the forecast period primarily owing to rising demand in medical applications” (Grand View Research 2019).

Industry insiders have long known that oil and extract sales would outgrow flower sales. This is in part because of the discrete nature of oil consumption, but also due to the fact that smoking cannabis is viewed as an unnecessary health hazard. When talking about extracts, it is important to distinguish the difference between ‘isolate’ and ‘full spectrum’ end products:

The pie chart on the right demonstrates the domination of ‘full spectrum’ concentrates versus ‘isolates,’ which speaks volumes to the public’s belief in the therapeutic effects of an ‘entourage effect’ caused by the consumption of full spectrum extracts. Whether you’re looking to create full spectrum or isolate THC/CBD end products, our formulations professionals have got you covered.

Even the long-running, financial juggernaut of a publication in Forbes has jumped on the cannabis bandwagon. The article, Legal Cannabis Industry Poised For Big Growth, In North America And Around the World, cites Arcview Market Research, and its research partner BDS Analytics, assessment for the next 10 years:

“…the legal cannabis industry will see much progress around the globe. Spending on legal cannabis worldwide is expected to hit $57bn by 2027. The adult-use (recreational) market will cover 67% of the spending; medical cannabis will take up the remaining 33%” (Forbes 2018).

That’s $57bn worldwide by 2027… billion, with a “b.” Based on the financial projections and graphs above, one can see the importance of early positioning in a burgeoning marketplace with a focus on scaling up in phases.

In the Health Europa Quarterly article, Time to get acquainted with the industrial hemp revolution in Europe, the manager of New Frontier Data, Rob Kuvinka, states that: “Used in Europe for more than 3,200 years, hemp today represents an annual market opportunity of $1 bn (~€692m) for the continent, and over $3.7bn globally in 2018… First-mover advantages may allow European producers to capitalise on growing global demand for CBD. Growth in CBD will be largely driven by the United States, where CBD sales are expected to grow at a 36% CAGR until 2022” (Health Europa Quarterly 2019).

Statistics from the Hemp Business Journal reveal that of the $3.7 bn of global hemp based product sales by country in 2018 that 29% of sales were done in the USA, while Europe was a close second with 27% (Health Europa Quarterly 2019).

Getting started: research and due diligence

If you are just getting started, it’s easy to feel overwhelmed with the plethora of information and claims floating around. Whether you’re looking to start out doing lab sized batch processing or industrial scale, we have the experience necessary to help you efficiently start out and build up, with any number of our scalable full solutions.

If you’re looking to get into the cannabis and hemp industries, the use of multiple consultants is a key to certain failure. We have spent many hours educating ‘customers’ who we later find out are consultants trying to serve their clients. Thompson notes, “Our experience goes deeper than just consulting. However, I would like to say that ‘we have seen it all’ with all these installations. In reality, sometimes we get surprised.” Having a collaborative approach to solve startup problems is our goal so that we can leave the customer trained and ready to produce. If you have any questions, feel free to contact us.

Further reading
Cannabis Extract Market Size, Share & Trends Analysis Report By Product, By Extract Type, By Country, Competitive Landscape, and Segment Forecasts, 2019-2025.” Grand View Research: May 2019. Website: https://www.grandviewresearch.com/industry-analysis/cannabis-extract-market
Time to get acquainted with the industrial hemp revolution in Europe. Health Europa Quarterly Issue 10 July 2019. Website: https://www.healtheuropa.eu/industrial-hemp-revolution/92912/
Moser, Simon. The Legal Situation of Hemp, Marijuana and CBD in the EU in 2019. StrainInsider: March 11 2019. Website: https://straininsider.com/legal-situation-cannabis-europe
Pellechia, Thomas. Legal Cannabis Industry Poised For Big Growth, In North America And Around the World. Forbes: March 1 2018. Website: https://www.forbes.com/sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-worldwide-cannabis-market-lead/#6a9945716510
PR Newswire. United Science Calls on Industry to Prepare for Emerging Cannabis Commodity Market. Cision PR Newswire: May 30 2019. Website: https://www.prnewswire.com/news-releases/united-science-calls-on-industry-to-prepare-for-emerging-cannabis-commodity-market-300859226.html

Dr Jon ThompsonCEOUnited Science LLC+1 651 362 9556jthompson@unitedscience.com

Please note, this article appeared in issue 11 of Health Europa Quarterly, which is available to read now.

Source link

Previous Carrying hemp? You might need to carry a license for that - Georgia Recorder
Next Hemp – A Year in Review Cannabis - Industry News Alert - JD Supra